Trial reportSleep2015
Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes.
Trial report in Sleep, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01418209 (MsFLASH-03), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy of hormone therapy and phytoestrogens on the psychological symptoms of menopausal women: a systematic review, meta-analysis, and trial sequential analysis.Frontiers in medicine · 2026Pooled it
- Effects of oral versus transdermal menopausal hormone treatments on self-reported sleep domains and their association with vasomotor symptoms in recently menopausal women enrolled in the Kronos Early Estrogen Prevention Study (KEEPS).Menopause (New York, N.Y.) · 2018Trial
- Trial
- Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.JAMA internal medicine · 2016Trial
- Is Anxiety Associated with Vasomotor Symptoms in Postmenopausal Women with Insomnia Complaints?Sleep science (Sao Paulo, Brazil) · 2025Article
- Caloric Restriction, the Menstrual Cycle, and Sleep in Women Without Obesity.The Journal of clinical endocrinology and metabolism · 2025Article
- Sleep Disturbance and Perimenopause: A Narrative Review.Journal of clinical medicine · 2025Review
- A Cross-Sectional Study on the Relationship Between Urinary Enterolactone and Sleep Quality in American Obese Adults.Nature and science of sleep · 2025Article
- Association of Sleep Duration With Serum Estradiol Concentrations Among American Men and Women: Evidence From NHANES 2013-2016.International journal of endocrinology · 2025Article
- Insomnia in Postmenopausal Women: How to Approach and Treat It?Journal of clinical medicine · 2024Review
- Review
- Sex and Sleep Disruption as Contributing Factors in Alzheimer's Disease.Journal of Alzheimer's disease : JAD · 2024Review
- The Current Strategy in Hormonal and Non-Hormonal Therapies in Menopause-A Comprehensive Review.Life (Basel, Switzerland) · 2023Review
- Insomnia among Cancer Patients in the Real World: Optimising Treatments and Tailored Therapies.International journal of environmental research and public health · 2023Review
- Correlation among sleep quality, physical frailty and cognitive function of the older adults in China: the mediating role.Frontiers in public health · 2023Article
- Disturbed sleep is associated with reduced verbal episodic memory and entorhinal cortex volume in younger middle-aged women with risk-reducing early ovarian removal.Frontiers in endocrinology · 2023Article
- B serum proteome profiles revealed dysregulated proteins and mechanisms associated with insomnia patients: A preliminary study.Frontiers in integrative neuroscience · 2022Article
- Contemporary Non-hormonal Therapies for the Management of Vasomotor Symptoms Associated with Menopause: A Literature Review.TouchREVIEWS in endocrinology · 2021Review
- Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep.Journal of patient-reported outcomes · 2021Article
- Role of Ovarian Hormones in the Modulation of Sleep in Females Across the Adult Lifespan.Endocrinology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
STUDY
objectivesDetermine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes.
design3-arm double-blind randomized trial. Participants assigned in a 2:2:3 ratio to 17β estradiol 0.5 mg/day (n = 97), venlafaxine XR 75 mg/day (n = 96), or placebo (n = 146) for 8 weeks.
settingAcademic research centers.
participants339 community-dwelling perimenopausal and postmenopausal women with ≥2 bothersome hot flashes per day. MEASUREMENTS AND
resultsInsomnia symptoms (Insomnia Severity Index [ISI]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at baseline, week 4 and 8; 325 women (96%) provided ISI data and 312 women (92%) provided PSQI data at baseline and follow-up. At baseline, mean (SD) hot flash frequency was 8.1/day (5.3), mean ISI was 11.1 (6.0), and mean PSQI was 7.5 (3.4). Mean (95% CI) change from baseline in ISI at week 8 was -4.1 points (-5.3 to -3.0) with estradiol, -5.0 points (-6.1 to -3.9) with venlafaxine, and -3.0 points (-3.8 to -2.3) with placebo (P overall treatment effect vs. placebo 0.09 for estradiol and 0.007 for venlafaxine). Mean (95% CI) change from baseline in PSQI at week 8 was -2.2 points (-2.8 to -1.6) with estradiol, -2.3 points (-2.9 to -1.6) with venlafaxine, and -1.2 points (-1.7 to -0.8) with placebo (P overall treatment effect vs. placebo 0.04 for estradiol and 0.06 for venlafaxine).
conclusionsAmong perimenopausal and postmenopausal women with hot flashes, both low dose oral estradiol and low-dose venlafaxine compared with placebo modestly reduced insomnia symptoms and improved subjective sleep quality. CLINICAL
trial registrationNCT01418209 at www.clinicaltrials.gov.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.